HB0025 with chemotherapy as first-line treatment for advanced or recurrent endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase III trial evaluating HB0025 plus paclitaxel and carboplatin versus placebo plus the same chemotherapy in first-line treatment of advanced (Stage III/IV) or recurrent pMMR endometrial cancer. Approximately 333 patients will be randomized 2:1 to receive HB0025 or placebo alongside chemotherapy every 3 weeks for 6 cycles, followed by maintenance therapy. The primary endpoint is progression-free survival as judged by blinded independent central review, with safety and other outcomes monitored throughout. Eligible participants are adults with confirmed pMMR endometrial cancer who have not received prior systemic anti-tumor therapy for this disease and meet specific pathology and consent criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged 18 years or older at screening.
2. Able to fully understand and voluntarily sign the informed consent form, and are willing and able to follow the clinical trial and subsequent visit procedures.
3. Patients diagnosed with advanced (stage III/IV, classified according to the 2009 International Federation of Gynecology and Obstetrics (FIGO)) or recurrent endometrial cancer, whose pathological type include but are not limited to endometrial adenocarcinoma, serous carcinoma, clear cell carcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, mixed carcinoma, carcinosarcoma (excluding uterine sarcoma), and confirmed as pMMR in the central laboratory.
4. Patients who had not received any systemic anti-tumor treatment for endometrial cancer in the past and are not suitable for radical surgical resection and/or radical concurrent radiotherapy.
5. Agree and can provide sufficient and qualified tumor tissue samples from the primary site or metastatic site (either archived tissue samples from the past 3 years before randomization or fresh tissue samples) for the detection of MMR and PD-L1 status.
6. ECOG PS of 0-1.
7. Adequate organ function.

Exclusion Criteria:

1. Second primary malignancy within 5 years before screening.
2. Brain metastases accompanied by central nervous system symptoms.
3. Previously treated with immune checkpoint inhibitors and/or anti-angiogenic drugs.
4. Those who underwent surgery within 4 weeks before the first treatment , or suffered from major traumatic injuries, or were judged by the researchers to have not fully recovered from previous surgeries, or were expected to require surgery during the study period.
5. Arterial hypertension that remains uncontrolled even after receiving standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
6. Those who have had or currently have interstitial lung disease, pneumoconiosis, drug-related pneumonia, or severely impaired lung function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity.
7. Pregnant or lactating women.
8. Known psychiatric disorder, alcoholism, drug addiction or substance abuse.
9. Participant who, in the opinion of the investigator, are unsuitable to participate in this trial for any other reason.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of China Medical University
  Shenyang, Liaoning, China Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.